ECHOGENIC NEEDLE
An echogenic needle may have at least one V-shaped spiral groove formed at its distal portion adjacent to its patient end. The walls of the groove are orthogonal to each other. The groove is titled at a given angle from a neutral position toward the proximal end of the needle so that when the needle is inserted into the patient at an insertion angle under ultrasound imaging, the ultrasound wave emitted from the ultrasound transducer is reflected in a substantially reverse direction back to the transducer by at least one wall of the spiral groove. A pair of crisscrossing grooves may be spirally wound about the distal portion of the needle with each groove being tilted to the given angle to enhance echogeneity. The echogeneity of the needle may also be enhanced by increasing the pitch density of each groove while maintaining the crisscrossing groves at their neutral position.
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This application is a divisional of, and claims priority from, application Ser. No. 17/679,331 filed on Feb. 24, 2022. The '331 application in turn claims priority from application Ser. No. 15/297,731 filed on Oct. 19, 2016 claiming priority from provisional application No. 62/246,205 filed on Oct. 26, 2015. The disclosures of application Ser. Nos. 17/679,331 and 15/297,731 in their entirety are hereby incorporated by reference.
FIELD OF THE INVENTIONThe present invention relates to echogenic medical devices, and more particularly a needle that may be used for peripheral nerve block (PNB) procedures having echogenic features at its patient end.
BACKGROUND OF THE INVENTIONThere are numerous echogenic needles known. Among them is the Wallace Amniocentesis Needles that are being sold by the assignee of the instant invention. The instant invention aims to improve the echogeneity of the echogenic features of needles use for different surgical procedures including peripheral nerve block (PNB), epidural and others that require ultrasound viewing of the needle during the procedure.
SUMMARY OF THE PRESENT INVENTIONThe echogenic needle of the instant invention has at its distal portion adjacent its patient end at least one section that has a spiral V-shaped groove. The walls of the groove are orthogonal to each other. The groove may be tilted at a given angle from its neutral position toward the proximal end of the needle. The inventive needle is usually inserted into a subject patient at a desirable insertion angle. If the needle is under ultrasound imaging whereby an ultrasound wave is directed to the needle, at least one wall of the tilted groove would reflect the ultrasound wave back to the receiver of the transducer at substantially the reverse direction, i.e., at approximately 180°, to present an improved ultrasound image of the echogenic needle. Also, by decreasing the pitch between the adjacent tips formed by the V-shaped groove, the density of the number of turns for the groove increases. As a result, an enhanced ultrasound wave is reflected back to the receiver of the transducer to provide an improved image of the echogenic needle, even were the groove not tilted at the aforenoted given angle.
In one embodiment, by forming the echogenic groove in a spiral fashion, while maintaining the preferred tilt angle to the groove, the echogenic needle of the instant invention may be made simply. Moreover, that the walls of the groove are orthogonal to each other means that the only angle that needs to be adjusted with regard to the production of the echogenic needle is the tilt angle, which may simply be done by adjusting either the angle of the needle shaft that is being cut, or the angle of the cutting wheel or tool used to cut the groove as the needle shaft is rotatably moved relative to the cutting wheel, which may also be rotating. In an other embodiment, the pitch (of the sidewalls) of the groove is further decreased so as to increase the pitch density for the spiral groove to a range that leads to an improved reflection of the ultrasound image. For the other embodiment, there may not be a need to tilt the groove.
Instead of one spiral groove, the echogenic section of the needle may be made with two crisscrossing spiral grooves, i.e., one clockwise and one counter-clockwise relative to the sharp tip of the needle. Each of the V-shaped grooves has walls that are orthogonal to each other. Furthermore, the grooves each may be tilted at a predetermined angle relative to the proximal end of the needle to effect a substantially 180° reflection of the ultrasound wave from the transducer back to the transducer, when the needle is positioned at an insertion angle that facilitates the insertion of the needle into the subject patient.
Instead of one echogenic section, the distal portion of the needle shaft may have a plurality of echogenic sections. For the exemplar embodiments, the needle shaft may have two echogenic sections separated by a non-groove section, so that there are two sections of crisscrossing spiral grooves each adapted to be tilted at a predetermine angle to reflect the ultrasound wave emitted from a transducer back to the transducer. In the other embodiment, the crisscrossing spiral sections are not tilted. Accordingly, the walls of each of the spiral grooves would have the same length while substantially orthogonal to each other.
The instant invention is therefore directed to a needle for viewing under ultrasound imaging that comprises a shaft extending along a longitudinal axis having a proximal end and a distal end including a sharp tip, one and other grooves spirally formed clockwise and counterclockwise, respectively, from at least adjacent the sharp tip along a distal portion of the shaft so that the one and other grooves crisscross each other a predetermined distance along the distal portion, the one and other grooves each being at a neutral position relative to the longitudinal axis of the shaft, each of the one and other grooves has an increased pitch density in a range that enhances the reflection of the ultrasound wave from an ultrasound transducer directed to the shaft as an improved reflection image back to the transducer. The walls of each of the grooves are orthogonal to each other and have the same length.
The present invention is further directed to a needle for viewing under ultrasound imaging that comprises a shaft extending along a longitudinal axis having a proximal end and a distal end including a sharp tip, one groove formed spirally from at least adjacent the sharp tip a predetermined distance along the shaft away from the sharp tip, the one groove being tilted from a neutral position to a tilt angle position toward the proximal end of the shaft so that an ultrasound wave from an ultrasound transducer directed to the shaft is reflected in a substantially reverse direction back to the transducer by at least a wall of the one groove when the shaft is positioned at an insertion angle for insertion into a subject.
The present invention is moreover directed to a needle for viewing under ultrasound imaging that comprises a shaft extending along a longitudinal axis having a proximal end and a distal end including a sharp tip, one and other grooves spirally formed clockwise and counterclockwise, respectively, from at least adjacent the sharp tip along a distal portion of the shaft so that the one and other grooves crisscross each other a predetermined distance along the distal portion, each of the one and other grooves being tilted from its neutral position to a tilt angle position toward the proximal end of the shaft so that an ultrasound wave from an ultrasound transducer directed to the shaft is reflected in a substantially reverse direction back to the transducer by at least a wall of each of the one and other grooves when the shaft is positioned at an insertion angle for insertion into a subject.
The present invention will become apparent and the invention itself will be best understood with reference to the following description of the present invention taken in conjunction with the accompanying drawings, wherein:
An exemplar embodiment of the inventive needle used, for example for peripheral nerve block procedures, is shown in
As shown in
As best shown in
The configuration of the groove of the needle is illustrated in
The inventors have found that, in use, a clinician usually positions a needle at an angle that facilitates the insertion of the needle into the subject. Thus, were the groove “tilted” at a given angle α toward the proximal end of the needle, an improved reflection of an ultrasound wave directed by an ultrasound transducer towards the needle may be obtained. By empirical studies, it was found that the α angle may range from approximately 5° to 25°, and preferably at 10° relative to the neutral position. Thus, instead of 45° for each of the walls of the V-shaped groove, the “tilted” groove would have its walls, as designed by lines 16w1′ and 16w2′, shifted together such that wall 16w1′ is at a β angle relative to the outside walls 4a of the needle shaft. Walls 16w1′ and 16w2′ remain orthogonal to each other when at the “tilted” position. For the exemplar embodiment where α=10°, β would be 35°. The depth of the groove may vary anywhere from 0.006 inch to 0.025 inch (0.1524 mm to 0.635 mm). It is further found that the pitch between grooves, as designated by reference number 24 in
The configuration of the exemplar embodiment of the echogenic needle of the instant invention is further shown in
As discussed above, with the exemplar illustration as shown in
The neutral positioned spiral grooves are represented by the dotted wall lines 16w1 and 16w2 in
With the combination of clockwise and counter-clockwise spiral wound grooves, and with each of the grooves having a preferable pitch of approximately 0.020 inch (0.508 mm) for the tilted echogenic needle embodiment, an echogenic needle with improved echogeneity results. So, too, an improved echogenic needle adapted to provide improved echogeneity results may be achieved with non-tilted crisscrossing clockwise and counter-clockwise spiral grooves each having an increased pitch density or groove width having a range of 0.001 inch to 0.003 inch (0.025 mm to 0.075 mm), and preferably of approximately 0.0021 inch (0.053 mm). It should be appreciated that instead of a V-shaped groove, each of the grooves may be U-shaped or some other shape such as trapezoidal-shaped, so long as the walls of the groove are made to be substantially orthogonal to each other. Furthermore, one of the crisscrossing grooves may have a V-shape while the other groove may have a U-shape or some other shape including trapezoidal that clearly defines the orthogonal walls of the groove.
Although not disclosed above, it should be appreciated that the proximal end of the needle may be fixedly bonded or connected to a needle hub, so that the needle may be fluidly coupled to a medicament or fluid store, such as a syringe or a pump, to infuse medicament or fluid to the patient once the needle has been inserted into and appropriately positioned within the patient. The respective connectors of the needle hub and the fluid store may be configured to have complementary features or configurations that allow only those connectors to be coupled to each other, i.e., each of those connectors is not connectable to a counterpart conventional luer connector. Moreover, before use, the needle may be protected by a sleeve to prevent contamination and for shipping purposes. To prevent coring of the needle, a stylet may be concentrically fitted into the through passage of the needle when the needle is inserted into the patient, and removed thereafter.
The forming of the spiral grooves onto the outer circumferential wall of the needle shaft may be accomplished in substantially the same manner as is done for the above-noted Wallace Amniocentesis Needles. In the alternative, the spiral grooves may be formed substantially in accordance with the disclosure of JP2000051219, which was assigned to the assignee of the instant invention. In brief, the '219 publication discloses an edge of a spinning wheel is used to form a groove on a catheter that rotatably moves along a longitudinal direction relative to the wheel.
Inasmuch as the present invention is subject to many variations, modifications and changes in detail, it is intended that the matter described throughout this specification and shown in the accompanying drawings be interpreted as illustrative only, and not in a limiting sense. Accordingly, it is intended that the invention be limited only by the sprit and scope of the hereto appended claims.
Claims
1. A method of making an echogenic needle having a shaft that has a sharp distal tip, a proximal end and an outer circumferential surface, comprising:
- positioning relative to the needle a tool adapted to cut a groove having walls orthogonal to each other onto the outer circumferential surface of the needle so that walls having the same length would be formed onto the outer circumferential surface of the needle were the needle to lie along a longitudinal axis relative to the tool at a neutral position;
- repositioning the needle and the tool relative to each other at an angle tilted away from the neutral position; and
- rotatably moving the tool and the shaft of the needle relative to each other to cut a spiral groove having a tilt angle relative to the neutral position onto the outer circumferential surface of at least one section of the needle.
2. The method of claim 1, further comprising:
- repositioning the angle to tilt toward the proximal end of the needle.
3. The method of claim 1, further comprising:
- preferably positioning the tilt angle to be at 10° away from the neutral position.
4. The method of claim 1, further comprising:
- forming the spiral groove at multiple sections of the needle.
5. The method of claim 1, further comprising:
- forming the spiral groove in one direction along the at least one section of the needle; and
- rotatably moving the tool and the shaft of the needle relative to each other to form another spiral groove having another tilt angle onto the outer circumferential surface of the needle in another direction along the at least one section such that the spiral groove formed along the one direction and the another spiral groove formed along the another direction crisscross each other.
6. The method of claim 1, further comprising:
- forming the spiral groove having the tilt angle to have a pitch of approximately 0.020 in (0.508 mm).
7. The method of claim 1, further comprising:
- varying the tilt angle from approximately 5° to 25°.
8. The method of claim 7, further comprising:
- forming the spiral groove to have a V-shape.
9. The method of claim 7, further comprising:
- forming the spiral groove to have a non-V shape.
10. A method of making an echogenic needle having a shaft including a sharp distal tip and a proximal end with an outer circumferential surface having at least one section thereon adapted to reflect ultrasonic waves directed thereat in a substantially reverse direction, comprising:
- positioning relative to the needle a tool adapted to cut a groove having walls orthogonal to each other onto the outer circumferential surface of the needle so that walls having the same length would be formed onto the outer circumferential surface of the needle if the needle were to lie along a longitudinal axis relative to the tool at a neutral position;
- repositioning the needle and the tool relative to each other at an angle tilted away from the neutral position; and
- rotatably moving the tool and the shaft of the needle relative to each other to cut a spiral groove having a tilt angle relative to the neutral position onto the outer circumferential surface along the at least one section of the needle with the walls of the groove remaining orthogonal to each other.
11. The method of claim 10, further comprising:
- tilting the angle toward the proximal end of the needle.
12. The method of claim 10, further comprising:
- tilting the angle toward the proximal end of the needle from approximately 5° to 25°.
13. The method of claim 11, further comprising:
- preferably tilting the angle to be at 10°.
14. The method of claim 11, further comprising:
- rotatably moving the tool in another direction relative to the shaft of the needle to form another spiral groove having another angle onto the outer circumferential surface of the needle along another direction different from the direction of the spiral groove such that the spiral groove and the another spiral groove crisscross each other at the at least one section of the needle.
15. The method of claim 11, further comprising:
- forming crisscrossing spiral grooves at multiple sections of the needle.
16. The method of claim 11, further comprising:
- forming the spiral groove to have a pitch of approximately 0.020 in (0.508 mm).
Type: Application
Filed: Jun 28, 2024
Publication Date: Oct 31, 2024
Applicant: SMITHS MEDICAL ASD, INC. (Plymouth, MN)
Inventors: Andrew Crisman (Shoreview, MN), Alysa Lauren Granata (Minneapolis, MN)
Application Number: 18/757,712